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Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)

NCT ID: NCT03796494

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-01-08

Brief Summary

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This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.

Detailed Description

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Conditions

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Dental Implant Failed Dental Prosthesis Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

The control group is considered, using the company's classic multi-position straight anti-rotational abutment

Group Type ACTIVE_COMPARATOR

Straight abutment

Intervention Type PROCEDURE

This is the classic abutment, straight and anti-rotational for dental implants which have been tested before

Test group

The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used

Group Type EXPERIMENTAL

Slim abutment

Intervention Type PROCEDURE

This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space

Interventions

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Straight abutment

This is the classic abutment, straight and anti-rotational for dental implants which have been tested before

Intervention Type PROCEDURE

Slim abutment

This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients without systemic pathology that are grounds for absolute contraindication
* Older adults who agree to be part of the study and sign the informed consent
* Consumption of tobacco less than 5 cigarettes / day
* Do not be completely toothless
* Absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. In case of odd absences (3,5,7), a Slim pillar will be placed, being the group to always be the majority.
* Area of mature bone healed at least 6 months post-extraction.
* Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long

Exclusion Criteria

* Immunosuppressed
* Aesthetic edentulous areas of 13-23 and 33-43
* Smokers of more than 5 cigarettes
* Index of bleeding greater than 30%
* Patients with less than 2 mm of keratinized gingiva
* Implants with primary stability with ISQ \<55
* Implants with ISQ index \<55 at 8 weeks
* When a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galimplant Dental Implants

OTHER

Sponsor Role collaborator

University of Santiago de Compostela

OTHER

Sponsor Role lead

Responsible Party

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Mario Pérez Sayáns

Professor Mario Perez Sayans MD, PhD (Principal investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mario Pérez Sayáns

Santiago de Compostela, A Coruña, Spain

Site Status

Countries

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Spain

Related Links

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http://imaisd.usc.es/grupoficha.asp?idpersoatipogrupo=75189&i=es&s=-2-26-148

GI-1319

Other Identifiers

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CT-2019-01

Identifier Type: -

Identifier Source: org_study_id